This invention relates to urinary irrigation devices, and, more particularly, to closed irrigation sites for urinary drainage systems.
A long-term urinary drainage system typically has a self-retaining catheter, drainage tubing, and a collection bag, all in fluid communication. Such urinary drainage systems require periodic irrigation of the catheter with a sterile normal saline solution or water, to prevent blood clots and the like from obstructing the system. Common irrigation practice has required a break in the closed drainage system, which, of course, allows the entrance of air which may carry contaminates into the closed system, creating the possibility of infection. Medical studies have shown that urinary tract infections during catherization are widespread, particularly after a catheter remains indwelling for several days.
Various attempts have been made to reduce or eliminate the likelihood of infection. Such measures have included improvement of the design of catheters, use of prophylactic antibiotics, attempts to maintain a completely closed system, and the use of closed irrigation access sites through which an irrigant is introduced.
Some urinary drainage devices provide irrigation without ever breaking the closed system. For example, some systems have utilized continuous attachment of an irrigation set. This sort of device, however, is bulky and prevents freedom of movement for ambulatory patients.
More recent devices have included closed irrigation access sites through which an irrigant may periodically be introduced. One of such devices, commonly called irrigation valves, is that shown in U.S. Pat. Nos. 3,577,992 and 3,965,910. Such irrigation valves are difficult or impossible to properly disinfect or "prep" prior to irrigation. The inherent complexity of design of such valves provides corners, spaces, and gaps which cannot be cleaned thoroughly, and, therefore, provide an opportunity for bacterial growth. The bacteria, rather than being disinfected, are washed into the system and into the patient. Such devices have the further disadvantage of their internal structure tending to impede the flow of irrigating fluid from the syringe source to the bladder. Furthermore, in some cases the structure will impede the normal drainage flow from the bladder to the collection bag.
Needle injection sites cannot advantageously be used for irrigation purposes because, while such sites would eliminate introduction of contaminated air, they would not allow a sufficient flow of irrigating fluid.
Devices such as that disclosed in U.S. Pat. No. 3,994,293 (Ferro), while allowing greater flow, would impede the flow of irrigant from a syringe source. Furthermore, such devices are difficult to properly prep, having an area which is exposed to the air but nearly inaccessible to swabbing.